FDA Says Da Vinci Robot Stall Issues Warranted a Class II Recall

Posted By
The Gilbert Law Group

Following Intuitive Surgical Inc.’s warning late last year that the
instruments used in its da Vinci robots can stall for a brief moment during
surgical procedures, the Food and Drug Administration put out a notice
classifying this issue as a Class II recall. When the FDA makes this type
of recall, it means that the agency believes that the product may cause
health problems that are “temporary or medically reversible,”
as well as more serious health issues. That said, the instruments have
not actually been recalled from the market. However, inspections are taking
place to see whether the devices need to be repaired or replaced.

At The Gilbert Law Group®, our surgical robot claims lawyers believe that
Intuitive Surgical has been very persuasive in promising that these medical
devices will improve results and patient recovery, which is why over 300
hospitals in the US alone are currently using them in about 350,000 procedures
a year. Our product defects law firm remains very concerned about the
injuries and deaths that have occurred during robotic surgery.
The New York Times reported last year that according to a study published in The Journal
for Healthcare Quality, there had been at least 71 deaths and 174 injuries
related to da Vinci procedures. The number of da Vinci injury lawsuits
claiming products liability over this device continue to go up.

The American Association for justice writes that in 2013 alone, there were
at 3,697 reports of injury, death or malfunction involving the da Vinci
Robot—up significantly from the 1,595 incidents reported in 2012.
(While previous underreporting may be the cause of this spike, the medical
devices are used in a number of procedures.) The FDA wants doctors and
hospitals to get proper, complete training before using the robots.

Intuitive Surgical put out this latest warning after three customers submitted
incident reports. The problem appears to involve friction in the arms
of the instrument, which can disrupt their motion. Close to 1,400 instruments
are involved globally, although there are less da Vinci robots involved
because some of them work with more than one instrument. The da Vinci
robots let doctors perform procedures that are minimally invasive using
a computer console to control the device’s different instruments.

The FDA also put out a class II recall for certain da Vinci EndoWrist needle
driver lots, which guide and hold the instruments, over concerns that
the jaw inserts of the driver may detach. The American Association for
Justice says Intuitive Surgical has received reports of 82 incidents involving
these faulty or detached inserts. In 27 of the incidents, the inserts
came off during a surgical procedure. One patient had to undergo a second
surgery to remove a device fragment that fell in during the first procedure.

Whether it was because a da Vinci robot was defective or surgeons were
improperly trained, your injury or a loved one’s death might have
been preventable. Please contact our products defects law firm to explore
your legal options. Your case consultation with us is a free, no obligation
case assessment.